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V181 dengue vaccine for healthy children ages 2 to 17

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT07013487

This trial will test whether the V181 dengue vaccine is safe, triggers protective immunity, and reduces dengue infections in healthy children aged 2 to 17.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment12000 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations40 sites (East Jakarta, Jakarta Special Capital Region and 39 other locations)
Trial IDNCT07013487 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 3 trial enrolls healthy children aged 2 to 17 who receive either V181 or placebo to measure safety, immune responses, and reduction in virologically confirmed dengue. A Reactogenicity and Immunogenicity Subset of about 3,600 participants will be followed for safety and immunogenicity through 28 days after vaccination. A Long-term Immunogenicity Subset of roughly 620 participants, randomly selected from the reactogenicity group, will have virus reduction neutralization testing (VRNT) at scheduled timepoints for up to five years. Primary outcomes include tolerability, serologic immune response, and reduction in virologically confirmed dengue of any severity across all four serotypes regardless of baseline dengue serostatus.

Who should consider this trial

Good fit: Healthy children aged 2 to 17 years without known immunodeficiency, active hepatitis B/C, serious chronic illness, or contraindications to vaccination or venipuncture are ideal candidates.

Not a fit: Children with impaired immune function, documented HIV or hepatitis B/C infection, serious progressive diseases, bleeding disorders, or certain neurological or developmental disorders are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, V181 could reduce dengue infections and protect children from illness caused by any of the four dengue serotypes.

How similar studies have performed: Previous dengue vaccines have produced mixed results—some offered protection mainly in seropositive individuals or had safety limitations—so a vaccine effective regardless of baseline serostatus would represent a notable advance.

Eligibility criteria

Show full inclusion / exclusion criteria 
The key Inclusion Criteria include but are not limited to:

* Is generally healthy based on medical history and physical examination.

The key Exclusion Criteria include but are not limited to:

* Has a known or suspected impairment of immunological function.
* Has a history of congenital or acquired immunodeficiency.
* Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.
* Has a documented history of hepatitis B or C infection.
* Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.
* Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.
* Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
* Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).
* Received systemic corticosteroids \<30 days before receipt of study intervention or is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.
* Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.
* Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.

Where this trial is running

East Jakarta, Jakarta Special Capital Region and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Healthy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.